Data Standards
Organized by domains and subdomains often used in clinical studies, data standards include:
- CDEs — Classified as Core, Supplemental–Highly Recommended, Supplemental, or Exploratory
- CRF Modules — Template forms that logically organize CDEs for data collection
- Guidance Documents — Provide further information about the CDEs
- Instrument Notice of Copyright (NOC) Documents — Include pertinent information on recommended instruments (Instrument Notice of Copyright Information)
Cerebral Palsy Start-up Resource Listing: All Core and Supplemental–Highly Recommended CDEs recommended for Cerebral Palsy study start-up
Cerebral Palsy Highlight Summary: Overview of all Cerebral Palsy-specific CDE recommendations as they appear on the website
Click Expand All to view the CDEs associated with the CRF modules, organized by domain and subdomain.
Overview
The Cerebral Palsy (CP) Common Data Elements (CDE) Working Groups and the National Institute of Neurological Disorders and Stroke (NINDS) CDE Team developed Version 1.0 of the CP CDEs in 2015 through a partnership between NINDS and the American Academy of Cerebral Palsy and Developmental Medicine (AACPDM).
To develop the Cerebral Palsy CDEs, the Cerebral Palsy CDE Working Group divided into subgroups to focus on identifying and defining data elements in the domains of:
- Engagement and Quality of Life Assessments/Data
- Health, Growth, Genetics, Comorbidities and Labs
- Neurocognitive, Social, and Emotional Assessments
- Neuroimaging Diagnostics
- Neuromotor Skills and Functional Assessments
- Participant Characteristics and Disease/Injury Related Events
Data standards include CDEs as well as case report form (CRF) Modules, Guidance documents and Instrument Notice of Copyright (NOC) documents. The CRF Modules logically organize the CDEs for data collection, the Guidance documents provide further information about the CDE, and the NOC documents include perinent information on recommended instruments. The CDE, CRF Modules, Guidance documents and NOCs presented are organized into domains which are intuitive and common in clinical research studies. Version 1.0 of the Cerebral Palsy CDEs were released in 2016.
The Cerebral Palsy CDE Oversight Committee (OC) was created in 2017 to periodically review, direct the updating, and advance the development of the CP CDEs.
Since 2017 the CP OC has convened regularly to develop CDEs beyond the defined data elements in the CP Version 1.0 domains. In 2018 the CP OC developed and posted the External Device – CP CRF, and in 2020 developed and posted the Participant Condition Characteristics CRF on the Cerebral Palsy data standards page.
In 2019 the CP OC convened to review validated instruments in the domain of chronic pain, and research standardized orthopedic surgeries and assessments for new CP CDEs. During this process, the CP OC formed two subgroups. The CP Pain subgroup recommended 15 Pain Instruments to assess chronic pain and the CP Orthopedic Surgery subgroup developed six CRFs and associated CDE data dictionaries for lower extremities.
After a public review period of the draft CP CDEs, from April 27, 2022 to June 1, 2022, the CP OC recommended 15 Pain Instruments and six Orthopedic Surgical CRFs and CDE Data Dictionaries were posted on the CP data standards page in August 2022. In September 2022, the CP Pain and CP Orthopedic Surgery subgroups presented the development of their respective CDEs and recommendations for pain instruments at the 76th Annual AACPDM Meeting in Las Vegas, NV.
Roster
The Cerebral Palsy (CP) CDE Working Group was comprised of seven different subgroups. Chairs were appointed to lead the overall Working Group and the individual subgroups. The Working Group members actively developed the CDEs for their specific subgroups and also had an opportunity to review and comment on the recommendations of the other subgroups. The CP CDE Working Group was supported by the NINDS CDE Team. The complete CP CDE Working Group roster and the rosters by Subgroup are shown below:
Publications
- Schiariti V, Fowler E, Brandenburg JE, Levey E, Mcintyre S, Sukal-Moulton T, Ramey SL, Rose J, Sienko S, Stashinko E, Vogtle L, Feldman RS, Koenig JI. A common data language for clinical research studies: the National Institute of Neurological Disorders and Stroke and American Academy for Cerebral Palsy and Developmental Medicine Cerebral Palsy Common Data Elements Version 1.0 recommendations. Dev Med Child Neurol. 2018 Oct;60(10):976-986. doi: 10.1111/dmcn.13723. Epub 2018 Mar 15. PMID: 29542813.
- Schiariti V, Shierk A, Stashinko EE, Sukal-Moulton T, Feldman RS, Aman C, Mendoza-Puccini MC, Brandenburg JE; National Institute of Neurological Disorders and Stroke Cerebral Palsy Common Data Elements Oversight Committee. Cerebral palsy pain instruments: Recommended tools for clinical research studies by the National Institute of Neurological Disorders and Stroke Cerebral Palsy Common Data Elements project. Dev Med Child Neurol. 2024 May;66(5):610-622. doi: 10.1111/dmcn.15743. Epub 2023 Aug 31. PMID: 37650571; PMCID: PMC10902183.
Updates
Please see attached revision history document. Please contact NINDSCDE@emmes.com if you require further information or have any questions about the revision history.
Cerebral Palsy CDEs Revision History
The need to develop a common data set of meaningful measurements for Cerebral Palsy (CP) was identified as a priority area of the American Academy of Cerebral Palsy and Developmental Medicine’s (AACPDM) 2013–2017 strategic plan. In 2015, the CP specific Common Data Elements (CDEs) were developed through a partnership between the National Institute of Neurological Disorders and Stroke (NINDS) and the AACPDM. Version 1.0 of the CP CDEs was posted on the CP Data Standards page in 2016.
In 2017, the CP CDE Oversight Committee (OC) was created to periodically review, direct the updating, and advance the development of the CP CDEs. Since 2017, the CP OC has convened regularly to develop CDEs beyond the defined data elements in the CP Version 1.0 domains. In 2018, the CP OC developed and posted the External Devices – CP case report form (CRF) and in 2020 developed the Participant Condition Characteristics CRF.
In 2019 the CP OC convened to review validated instruments in the domain of chronic pain, and research standardized orthopedic surgeries and assessments for new CP CDEs. During this process the CP OC formed two subgroups. The CP Pain subgroup recommended 15 pain instruments to assess chronic pain and the CP Orthopedic Surgery subgroup developed six CRFs and associated CDE data dictionaries for lower extremities.
The CP Pain subgroup reviewed a total of 184 assessments: 22 NINDS CDE CRFs across disorders; 23 NINDS CDEs across disorders related to pain; 101 pain measures from the NIH HEAL Initiative; and 38 from a literature review. These assessments were reviewed using the following criteria to recommend the selected 15 pain instruments:
- Assessment was developed specifically for chronic pain
- Assessment was developed for pediatric populations (children 0 to 18 years)
- Main focus of the assessment is pain
- more than 3 questions
- Assessment fits within one of the pain categories
- intensity, interference, behavior, quality, or location
- Assessment is available in English
The CP Orthopedic Surgery subgroup assessed the Cerebral Palsy Research Network’s (CPRN) Orthopedic Registry Elements to develop CP orthopedic surgery CDEs. The CPRN Orthopedic Registry Elements and Data Forms were chosen as a basis for these CDEs because these elements have been vetted by CPRN’s Orthopedic Registry Task Force of renowned orthopedic surgeons allowing the subgroup to select, organize and augment the registry elements more quickly to develop the NINDS Orthopedic Surgery CDEs.
The CP Pain Instruments and Orthopedic Surgery CRFs and CDE Data Dictionaries were posted on the CP data standards page in August 2022.
A complete listing of the Pain Instruments and Orthopedic Surgery CRFs and CDE data dictionaries may be found in the CP CDEs Revision History document linked above.